Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
研究概览
简要总结
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
详细描述
This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.
The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.
排除标准
- •Need for antibiotic treatment for any infections
- •Urological intervention or need for catheter change within study duration of 4 weeks
研究组 & 干预措施
Study arm with Oxys-Cathter
The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.
干预措施: Oxys Catheter (Device)
Control-arm with commercial catheter
The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
干预措施: Covidien Mona-Therm Foley catheter (Device)
结局指标
主要结局
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
时间窗: 4 weeks
次要结局
- Significant bacteriuria assessed by weekly bacterial cultures.(every week during 4 weeks)
- occurence of adverse events(within 4 weeks)
- Clinically symptomatic catheter associated lower urinary infections.(4 weeks)